Stability and Product Registration

Chemika has been serving Australian manufacturers for more than 10 years, offering a high quality, independent chemical testing service. We have an outstanding team of scientists that bring breadth and experience from around the world.

Our experience covers a diverse range of international compendial methods for analysis including BP,EU, JP, USP as well as customer supplied methods. 

  • amber_glass_vials_2013-07-18_13.22.30-1.jpg
  • clear_infusion_bag_2013-07-18_12.15.25-1.jpg
  • lab2013-07-18_09.22.00-1.jpg
  • scientists2013-07-18_14.41.22.jpg
  • stability.jpg

Since Chemika’s only activity is chemical testing, activities such as running stability trials are equally important to us as for example testing which forms part of a release protocol. Running stability studies within the contract laboratory has the added advantage of maintaining competence in the contract laboratory, and gives added assurances that the contract laboratory will have all equipment, standards and reagents in stock when testing for release is required.

Our commitment to industry has been reinforced with our new state of the art laboratory. It has been designed with stability needs in mind, with additional capacity for storage available. All Stability Trials are overseen by our Quality Control Department, you can rest assured that your requirements are strictly adhered to each step of the way. For agricultural chemicals, such as pesticides you might like to discuss accelerated stability options, helping you to get to market sooner.

 We plan and operate stability studies with the aim of achieving the following objectives:

  • To obtain data which allows a definitive conclusion to be made about the stability of a product.
  • To carry out the study in a timely and predictable manner.
  • To achieve the objectives of the study without the need for justifications, explanations and correspondence – the data “speaks for itself”.

Stability studies are typically undertaken for the following reasons:

  • Product Development:
    - Data for evaluation and optimisation of a formulation.
  • Product Registration:
    - Generation of data as part of a product registration dossier.
  • Post Registration:
    - On-going stability or validation of process changes. Data required to complete annual product review.

Chemika has designed protocols and run stability trials for many years. With this experience we have put together 8 points to be considered for the planning and implementation of a trial.

  1. Start with the product specification. The tests conducted through the trial are generally based on the specification.
  2. Design your stability protocol to comply with regulations.
  3. Establish the laboratory's competence in test methods before the initial timepoint.
  4. Develop and implement validation protocols appropriate for the measurement.
  5. Document methods thoroughly and reference consistently.
  6. Aim to achieve mass balance.
  7. Review data continually through the study.
  8. Act immediately in response to OOS/OOT.

Chemika has worked hard to become the independent laboratory of first choice, our commitment to quality drives us to solutions that meet the most stringent of international regulatory requirements.

Working with Chemika, you’re supporting a team with principles, dedicated to meeting your goal of improving the health and wellbeing, of all people, with over 10 years of experience in the area of chemical testing.

We look forward to hearing from you. Please contact us now to discuss your analytical requirements.